21 CFR § 1309.21 - Persons required to register.
(a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12 through 1310.13 of this chapter, the following persons must annually obtain a registration specific to the List I chemicals to be handled:
(1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter.
(b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)
(c) The registration requirements are summarized in the following table:
Summary of Registration Requirements and Limitations
| Business activity | Chemicals | DEA forms | Application fee | Registration period
(years) |
Coincident activities allowed |
|---|---|---|---|---|---|
| (1) Manufacturing | List I,
Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine |
New–510
Renewal–510a |
3,699 | 1 | May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. |
| (2) Distributing | List I,
Scheduled listed chemical products |
New–510
Renewal–510a |
1,850 | 1 | |
| (3) Importing | List I,
Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine |
New–510
Renewal–510a |
1,850 | 1 | May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. |
| (4) Exporting | List I,
Scheduled listed chemical products |
New–510
Renewal–510a |
1,850 | 1 |